CLINICAL EFFECT OF PUGAKHANDA AND AYUSH PVK GEL ON WHITE DISCHARGE
- Conditions
- Other specified conditions associated with female genital organs and menstrual cycle,
- Registration Number
- CTRI/2020/07/026626
- Brief Summary
The term leucorrhoea means, strictly speaking, an excessive normal vaginal discharge, however it has become a generic term covering any purulent vaginal discharge. Leucorrhoea is still a global problem in spite of many elaborate studies for past decades. It is a common problem which affects many women during their reproductive years. The discharge may range from excess of normal to one which is a part of wide spectrum of ailments. The most common cause of leucorrhoea is physiological, followed by vaginal infections due to bacteria, virus, fungi and parasites. Other causes include foreign bodies, cervicitis and atrophic vaginitis.
Normal vaginal flora consists of both aerobic and anaerobic bacteria, with Lactobacillus species being the predominant microorganisms and accounting for greater than 95% of all bacteria present. Lactobacilli are believed to provide defense against infection, in part by maintaining an acidic pH in the vagina and ensuring hydrogen peroxide is present in the genital environment.
**Rationale of the study:**
The word “*Swetapradara*†has not appeared in *Brihatrayee* i.e. C*haraka Samhita, Sushruta Samhita,* and *Astanga Hridaya*.) For white vaginal discharge *Swetastrava* or *Yonistrava* words have been used. Commentator *Chakrapani*, *Sharangadhara Samhita, Bhava Prakash, Yoga Ratnakara* have used the word *Swetapradara* for white vaginal discharge. *Swetapradara* or white discharge is a symptom of all gynecological disorders (*Yonivyapads*) developing due to vitiation of *Kapha* and *Vatakapha* (*Atyananda, Karnini, Acharana, Aticharana, Sleshmala, Upapluta* and *Prasramsini* *Yoniivyapada*). Commentator *Chakrapani* has explained the word *Pandura-Asrigdara* (Pale vaginal discharge) as *Swetapradara* (leucorrhoea) in his commentary. *Acharya* *Sushruta* has described it as a physiological discharge of women secreted during sexual act.
Recently, it has been demonstrated that many human pathogenic bacteria have developed resistance against several synthetic drugs. Available reports on lesser efficacy and more side effects of synthetic drugs necessitate alternative medicine. There are number of drugs mentioned in Ayurveda. Classical Ayurvedic compound *Pugakhanda* described in *Bhaishajyaratnavali* is used for thesuccessful treatment of Leucorrhoea since ancient times. *Panchavalkala kwatha* has been conventionally used for reducing infection and inflammation for centuries.
On the basis of textual and clinical experience compound drug *Pugkhanda* is selected for the clinical trial in patients of *Swetapradara. Ayush PVK* gel is another medicine which basically consist of stem barks of five plants mainly *Udumbara* (*Ficus racemosa*), *Plaksha* (*Ficus microcarpa*) *Ashwattha* (*Ficus religiosa), Nyagrodha (Ficus bengalensis)* and *Parisha* (*Thepsia populnea*). The aqueous extracts of the above said plants were developed in gel form for local application in vagina. In a previous study conducted by CCRAS in 2012, the vaginal application of PVK gel had similar clinical efficacy as allopathic treatment symptomatically. Therefore, this study plans to find out the efficacy of *Pugakhanda* & *Ayush* –PVK gel in the management of *Swetapradara* (Pathological Leucorrhoea).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 40
- 1.Married woman of age between 18 to 40 years.
- 2.Presence of discharge per vaginum with or without itching/burning sensation /dyspareunia /foul smell for at least one month.
- 3.Patient agrees to refrain from use of douches oral or intra-vaginal antibiotics or antifungal agents or lubricants during the entire study period.
- 4.Patient willing and agrees to participate for three months and signs informed consent.
- 1)Patient with Pelvic Inflammatory Disease (PID).
- 2)Patient with Abnormal Papanicolaou smear with Intra-epithelial or invasive cancer.
- 3)Patient with unexplained vaginal bleeding.
- 4)Abnormal findings on pelvic Sonography.
- 5)Patient with positive pregnancy test.
- 6)Patient with Fibromyoma, polyp ovarian tumour or cyst prolapse.
- 7)Systemic disease like heart disease tuberculosis and uncontrolled Diabetes Mellitus Hypertension and Severe anemia i.e Hemoglobin less than 7 gms 8)Use of antibiotics or local vaginal formulation within the previous month 9)Endocervical smear positive for gonococci, or positive VDRL HIV & HbsAg test 10)Patients who are currently participating in any other clinical trial or participated in past four weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the symptom-vaginal white discharge Foul smell vaginal itching vaginal burning sensation Burning Micturition Pain during intercourse Lower abdominal pain and any other associated symptom Baseline 15th 30th 45th 60th and 90th day
- Secondary Outcome Measures
Name Time Method Changes in quality of life of the women in Swetapradara (Pathological leucorrhoea) Baseline 60th day and 90th day.
Trial Locations
- Locations (2)
Regional Ayurveda Research Institute for Lifestyle Related Disorders Thiruvananthapuram
🇮🇳Thiruvananthapuram, KERALA, India
Regional Ayurveda Research Institute for Mother and Child health care (RARIMCH) Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
Regional Ayurveda Research Institute for Lifestyle Related Disorders Thiruvananthapuram🇮🇳Thiruvananthapuram, KERALA, IndiaDR MEGHNA P PPrincipal investigator9495129282drmeghnapp@gmail.com